| ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-112 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This document provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.
NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.
NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.5928 | Accessories, Soft Lens Products | Class 2 | LPN |
| §886.5928 | Accessories, Solution, Ultrasonic Cleaners For Lenses | Class 2 | LYL |
| §886.5928 | Case, Contact Lens | Class 2 | LRX |
| §886.5928 | Sterilizer, Soft-Lens, Thermal, Ac-Powered | Class 2 | HRD |
| §886.5928 | Sterilizer, Soft-Lens, Thermal, Battery-Powered | Class 2 | HRC |
| §886.5925 | Lens, Contact, (Disposable) | Class 2 | MVN |
| §886.5925 | Lens, Contact, For Color Vision Deficiency | Class 2 | NCZ |
| §886.5925 | Lens, Contact, For Reading Discomfort | Class 2 | NIC |
| §886.5925 | Lenses, Soft Contact, Daily Wear | Class 2 | LPL |
| §886.5925 | Lenses, Soft Contact, Extended Wear | Class 3 | LPM |
| §886.5925 | System, In-Office Tinting, Contact Lenses | Class 2 | MZD |
| §886.5918 | Products, Contact Lens Care, Rigid Gas Permeable | Class 2 | MRC |
| §886.5916 | Lens, Contact (Orthokeratology) | Class 2 | MUW |
| §886.5916 | Lens, Contact (Other Material) - Daily | Class 2 | HQD |
| §886.5916 | Lens, Contact (Rigid Gas Permeable), Extended Wear | Class 3 | MWL |
| §886.5916 | Lens, Contact, Orthokeratology, Overnight | Class 3 | NUU |
| Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994. Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1997. |